Aortic heart valve catheter
Supported bioprosthetic heart valve with compliant orifice ring
ApplicationNo. 12305624 filed on 06/20/2007
US Classes:623/2.18Resilient frame
ExaminersPrimary: Woo, Julian
Attorney, Agent or Firm
Foreign Patent References
International ClassA61F 2/24
DescriptionBACKGROUND OF THE INVENTION
Diseases and other disorders of the heart valves affect the proper flow of blood from the heart. Two categories of heart valve disease are stenosis and incompetence. Stenosis refers to a failure of the valve to open fully, due to stiffenedvalve tissue. Incompetence refers to valves that cause inefficient blood circulation by permitting backflow of blood in the heart.
Medication may be used to treat some heart valve disorders, but many cases require replacement of the native valve with a prosthetic heart valve. Prosthetic heart valves can be used to replace any of the native heart valves (aortic, mitral,tricuspid or pulmonary), although repair or replacement of the aortic or mitral valves is most common because they reside in the left side of the heart where pressures are the greatest.
Conventional heart valve replacement surgery involves accessing the heart in the patent's thoracic cavity through a longitudinal incision in the chest. For example, a median sternotomy requires cutting through the sternum and forcing the twoopposing halves of the rib cage to be spread apart, allowing access to the thoracic cavity and heart within. The patient is then placed on cardiopulmonary bypass support which involves stopping the heart to permit access to the internal chambers. Suchopen heart surgery is particularly invasive and involves a lengthy and difficult recovery period.
Percutaneous implantation of a prosthetic valve is a preferred procedure because the operation is performed under local anesthesia, may not require cardiopulmonary bypass, and is less traumatic. Various types of prosthetics are adapted for suchuse. One class employs a stent like outer body and internal valve leaflets attached thereto to provide one way blood flow. These stent structures are radially contracted for delivery to the intended site, and then expanded/deployed to achieve a tubularstructure in the annulus. Another more advantageous class is offered by the assignee hereof. US Patent Publication No. 2005/0203614 (hereinafter "the '614 application," which application is incorporated by reference herein in its entirety) describes asystem in which various panels define the implant body carrying valve leaflets. These prosthetic valve structures are delivered in a contracted state and then unfolded and/or unrolled into an expanded state at the treatment location. An example of sucha valve is depicted in FIG. 1A. As shown, valve prosthesis 101 is adapted to carry a valve 107 having multiple leaflets 108. The valve support structure 106 includes a plurality of panels 109 that can transition from the state shown to an invertedstate as described in the '614 publication.
With either type of structure, a sufficient engagement between patient body tissue and the prosthesis body is desired to secure the position of the implant and form a peripheral seal. However, when implanting the prosthetic device at the siteof/within the envelope of the native valve, the condition of the native valve can interfere with fit. Stated otherwise, irregularity in the shape of the implantation site, surface features, texture, and composition pose challenges for developing animplant of a regular size able to accommodate all such variability.
Aspects of the invention optionally address the challenges presented by prosthetic member interface with calcific and/or irregular valve leaflet and annulus geometry. In addition, other advantages of the present invention may be apparent tothose with skill in the art upon review of the subject disclosure.
BRIEF SUMMARY OF THE INVENTION
This summary is provided by way of exemplary embodiments. In no way is this summary intended to provide limitation to the scope of the appended claims.
Accordingly, the systems and methods described herein include "docking" type devices for interfacing with replacement prosthetic valves. In some exemplary embodiments, these docking devices are in the form of a sleeve adapted to secure a valvebody within a central lumen, and interface with native tissue around its periphery. The docking sleeves can be adapted to provide a seal between the native valve or vessel and the valve body.
BRIEF DESCRIPTION OF THE DRAWINGS
The figures provided herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity. Each of the figures diagrammatically illustrates aspects of the invention. Variation of the invention from theembodiments pictured is contemplated.
FIG. 1A is a perspective view depicting an exemplary valve prosthesis.
FIG. 1B is an illustrative view depicting an exemplary embodiment of a docking system drawing relation to a heart.
FIGS. 2A-C are cross-sectional views depicting an exemplary embodiment of a docking system 100.
FIGS. 3A-B are axial and radial cross-sectional views, respectively, depicting additional exemplary embodiments of docking sleeve.
FIGS. 4A-B are axial cross-sectional and perspective views, respectively, depicting another exemplary embodiment of a docking sleeve.
DETAILED DESCRIPTION OF THE INVENTION
As opposed to known systems, an aspect of the systems and methods described herein contemplates more than a simple docking ring with a limited implant-retention interface. In the systems and methods described herein, the sleeve is adapted toreceive at least half, and more typically the entire valve body. Such overlap provides for valve/sleeve interface or securing approaches elaborated upon below. FIG. 1B is a illustrative view depicting a docking system 100 having a support structure 106of a valve prosthesis 101 as described in the '614 publication and a corresponding docking sleeve 102 adapted to receive valve support structure 106. Placement of the docking sleeve 102 can occur in a location corresponding to the presence of a nativevalve, such as the aortic valve within the aorta 103 of the heart 104 of a patient.
Another aspect of the systems and methods described herein that distinguish them from known stent-like and simple stent-graft docking structures is that the sleeves described herein offer a space-filling function to provide each of a goodinterface with irregular anatomy and a central lumen having a regular shape (e.g., circular, oval or elliptical) to accommodate corresponding valve body geometry. Stated otherwise, docking sleeves are provide that adapt to or take-up space and/orcompress or expand in sections to provide a superior vessel-side interface while offering an inner lumen with more regular geometry than the implantation site for valve body retention.
FIGS. 2A-C are cross-sectional views depicting an exemplary embodiment of a prosthesis 101 during various stages of deployment within aorta 103. In this embodiment, docking sleeve 102 is configured as a tissue graft with a variable thickness toconform to the underlying vessel anatomy (in this example, within aorta 103). Of course, in other embodiments, docking sleeve 102 can be composed of man-made materials and/or can be configured in a manner that does not enact full conformation with theunderlying anatomy. FIG. 2A depicts graft 102 carried on an expandable member (e.g., a balloon) 110 in its unexpanded state disposed on an elongate member (e.g., a catheter shaft) 111. FIG. 2B depicts graft 102 in a deployed configuration against thewalls of aorta 103 and filling sinus 112. The deployment of graft 102 is accomplished by inflation of balloon 110. FIG. 2C depicts graft 102 following the removal of balloon 110 and shaft 111 and the deployment of valve structure 106 (leaflets notshown). Here, it can be seen that structure 106 has a lesser length that graft 102, allowing greater freedom in the placement of structure 106. Also, graft 102 provides space-filling conformance with the underlying anatomy.
Such space-filling may be provided by a compliant body or body portion (e.g., biocompatible "spongy" foam such as expanded PTFE deflectable panels or leaf springs for a metallic material such as NiTi, a microporous polymer or metal/metal alloy,etc.), a multi-component/segment or composite body, or a body with a rigid implant-interface lumen and expandable exterior (e.g., as provided by a hydrogel, or permanently inflatable structure--via air, saline or another biocompatible fluid).
For a multi-component sleeve body, inner and outer tubular (e.g., cylindrical) sections may be provided with a spring media provided therebetween. Multiple elastomeric beams or metal spring (coil, torsion, zig-zag, etc.) elements may beemployed for such purposes. Alternatively, an air-spring approach with an interposed balloon (distensible or non-distensible) may be utilized. In the latter case, no additional seal element is required between the inner and outer sleeve housings. However, in the former case, one or more baffle structures (e.g. provided by woven fabric/fiber) may be employed to seal the body from inadvertent blood flow or passage/leakage. In order to avoid inadvertently supplying a cavity prone to thrombusformation, multi-piece sleeve bodies will typically be sealed-off at both ends.
FIGS. 3A-B are axial and radial cross-sectional views, respectively, depicting additional exemplary embodiments of docking sleeve 102 having an inner sleeve 114 and an outer sleeve 115. In FIG. 3A, inner sleeve 114 (which can also be valvesupport structure 106) and outer sleeve 115 are in spaced relation to each other in the deployed configuration with multiple spring elements 117, which are coiled springs in this embodiment, located and exerting force between the outer surface of innersleeve 114 and the inner surface of outer sleeve 115. Spring elements 118 serve to provide conformance to the underlying anatomy as well as to center inner sleeve 114 with respect to outer sleeve 115. Empty region 116 is configured to receive valvesupport structure 106 (not shown). Covering 118, which is a flexible fabric in this embodiment, is placed over the gap between sleeves 114 and 115 to seal the region therebetween from blood flow.
In FIG. 3B, docking sleeve 102 is shown in an exemplary intermediate undeployed configuration. Here, sleeves 114 and 115 are in a "tri-star" configuration similar to that described in the incorporated '614 application. Here, device 102 hasthree segments 123 arranged in a star-like manner. From this configuration, the profile of the device to be reduced further by rolling each segment towards the center axis 124. Sleeves 114 and 115 can be made to enter this configuration by inverting ordeflecting each of panels 121 and 122, respectively, towards the center axis 124 of the device in a manner similar to that described in the '614 application. Hinges 119 and 120 are included between panels 121 and 122, respectively, to facilitatetransition between the tri-star and deployed configurations. Although spring elements 117 can also be seen, covering 118 is not shown for clarity.
The length of the sleeve may vary as alluded to above. In order to bridge irregular anatomy such as the aortic sinus, the docking sleeve may be elongated relative to the valve body.
In a procedure for implanting a docking sleeve and prosthetic valve according to the present invention, various tissue modification techniques as described in commonly assigned, "Prosthetic Valve Implant Site Preparation Techniques," provisionalapplication Ser. No. 60/805,333, filed on Jun. 20, 2006 and incorporated by reference in its entirety, can be performed. However, in many instances, the current invention will allow foregoing approach without ill effect.
In one variation of the invention, a method is provided in which the docking sleeve is situated where its implantation is desired during a valvuloplasty procedure. After crossing the native valve leaflets, a balloon is expanded tosimultaneously open the leaflets and deploy the docking sleeve.
In order that the interfacing valve is readily available to complete the procedure without compromising patient hemodynamics for an extended period during a beating heart procedure (given that the native valve leaflets are pinned behind thedocking sleeve), the valve delivery device may also already be positioned in the aorta for immediate valve body insertion following docking sleeve or station deployment. Such a situation is facilitated by accessing the femoral artery in each leg of apatient to feed the different implant delivery systems (one from the right, and one from the left) into the aortic arch where there is sufficient room to accommodate both.
Alternatively, a temporary valve structure such as described in US Publication No. 2004/0225354 may be provided to allow advancement and delivery of the sleeve, withdrawal of its delivery catheter or guide and substitution for a valve bodydelivery guide for secondary implant delivery. US Publication No. 2001/0044591 discloses other approaches for percutaneous implant delivery that may alternatively be employed for delivering the docking sleeve and valve body.
As described above, the docking sleeve may be delivered upon a balloon--similar to delivery of a graft. In other variations where the implant comprises a plurality of flexible and/or hinged panels, it may be delivered in a fashion identical tothe approach to valve body delivery described directly below.
Specifically, in delivering a prosthetic valve assembly as described in US Publication No. 2005/0203614, after advancing the subject delivery system over the guidewire to the treatment location, its outer sheath is retracted to expose thedelivery tube. The gripper provided is then rotated relative to the delivery tube (or the delivery tube rotated relative to the gripper) to cause folded segments of the prosthetic valve to uncurl and to extend radially outward through longitudinal slotsof the delivery tube. The delivery tube is then retracted (or the gripper advanced) to cause the prosthetic valve (restrained by the fingers) to advance distally out of the delivery tube. The gripper is then retracted relative to the prosthetic valve,releasing the prosthetic valve into the treatment location. Preferably, the inverted segments then revert to the expanded state, causing the valve to lodge against the internal surface of the body lumen (e.g., the aortic valve root or anotherbiologically acceptable aortic position). Additional expansion of the prosthetic valve may be provided, if needed, by a suitable expansion member, such as an expansion balloon or an expanding mesh member (described elsewhere herein), carried on thedelivery catheter or other carrier.
In other methods, different types of prosthetic valves are delivered and deployed within the docking sleeve. In any case, either the valve body or the lumen of the docking sleeve (or both) may be specially adapted to provide a secure interfacebetween the members. Such adaptation may involve complementary VELCRO type hooks, protrusions, tines and loops, dimples, lattice spaces and/or cutouts. Otherwise, a frictional type interface or an interference fit may hold the bodies together. Anothermeans for securing the relative position of the members involves magnets. A plurality of discrete magnetic and/or ferromagnetic elements may be provided. Otherwise, one or both members may be at least partially constructed with magnetic impregnatedmaterial (such as polymeric sheet).
Common to all of the approaches, in accordance with another possibly independent aspect of the invention, is the manner in which a large portion or the entirety of the axial length of the implant is engaged with the docking sleeve. Thepreferred valve body variations have an axial length in which the valve leaflets are set. These "high walls" may help protect the leaflets (especially when closed-wall valve body structures are provided) and offer an advantageous docking memberinterface in terms of lateral stability as well as providing significant surface area for sturdy frictional, interlocking or other types of engagement between the members. Since the valve body will not be sutured to the docking sleeve (either an inneror outer portion thereof--as applicable) maximizing such contact, while still minimizing device size to aid in deliverability, can be important in providing a secure structure able to handle many millions of cycles of pulsing blood pressure.
Regarding the construction of the docking sleeve, its construction may substantially follow that in the '614 application for its valve bodies. Materials and assembly approaches for providing various "tri-star" and other types of docking sleevesconfigured as valve bodies presented in the '614 application are specifically contemplated. In some instances, the construction approaches will be modified to provide double-walled, double-cylinder or double-shelled valve docking/retention sleeves asprovided herein. With such an endpoint in mind, those with skill in the art can apply the relevant teachings. Generally speaking, the valve body is polymeric, NiTi alloy (where the Af is set for superelastic or SMA use), Beta Titanium alloy, or anothersuitable biocompatible material or another material with a robust biocompatible coating.
However constructed, it may be desirable to utilize largely closed or uninterrupted sleeve walls to avoid inward migration of native leaflets that can damage the prosthetic leaflets. In other instances, it may be desirable to strategicallylocate open sections in the sleeve walls to accommodate nested inner and outer portions without overlapping material. Stated otherwise, use of nesting cylinders/shells will avoid overlap resulting in thicker wall sections that can be more difficult tomanipulate into a reduce cross-section profile; or stack-up in size making fit within a percutaneous delivery system difficult.
In the latter case, overall valve system patency can be ensured by coordinating the valvular body configuration with the docking sleeve configuration so that holes provided in the outer member of the docking sleeve pair are covered or spannedwhen the valve body is set in place.
FIGS. 4A-B are axial cross-sectional and perspective views, respectively, depicting another exemplary embodiment of docking sleeve 102 having inner sleeve 114 and outer sleeve 115. FIG. 4A depicts sleeve 102 during deployment. Here, outersleeve 115 has an aperture 126 configured to receive inner sleeve 114 (which can also be valve support structure 106). Inner sleeve 114 is coupled to outer sleeve 115 by way of a sealing device, which in this embodiment is a fabric 128. Inner sleeve114 can be positioned within aperture 128 to prevent stack-up of the two sleeves 114 and 115 (i.e., an overlap between the sleeves 114 and 115 that increases the overall wall thickness). FIG. 4B depicts this embodiment while in the tri-starconfiguration. Fabric 128 is not shown.
In certain methods according to the present invention, the docking sleeve and valve body may be delivered simultaneously. Such an approach avoids the need for temporary valve approaches as described above. In yet another approach, the devices(i.e., the docking sleeve and valve member) are situated in series on a single delivery guide to allow for rapid, sequential deployment utilizing the same delivery device.
In another aspect of the method, the size of each of the prosthetic valve body and docking sleeve may be determined in various ways. Techniques described in U.S. patent application Ser. No. 11/420,189 entitled, "Assessment of Aortic HeartValve to Facilitate Repair or Replacement," filed May 24, 2006, may be helpful in this regard. Based on such measurement, appropriately sized docking sleeve and valve bodies may be selected for a given patient from stock or an organized panel ofdifferent-sized prostheses.
Various exemplary embodiments of the invention are described below. Reference is made to these examples in a non-limiting sense. They are provided to illustrate more broadly applicable aspects of the invention. Various changes may be made tothe invention described and equivalents may be substituted without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the present invention. Further, as will be appreciated by those with skill in the art that each of the individual variations described and illustrated herein has discrete components and featureswhich may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present inventions. All such modifications are intended to be within the scope of the appendedclaims.
Any of the devices described for carrying out the subject methods may be provided in packaged combination for use in executing the method(s). These supply "kits" may further include instructions for use and be packaged in sterile trays orcontainers as commonly employed for such purposes.
The invention includes methods that may be performed using the subject devices. The methods may all comprise the act of providing such a suitable device. Such provision may be performed by the end user. In other words, the "providing" actmerely requires the end user obtain, access, approach, position, set-up, activate, power-up or otherwise act to provide the requisite device in the subject method. Methods recited herein may be carried out in any order of the recited events which islogically possible, as well as in the recited order of events.
Exemplary aspects of the invention, together with details regarding material selection and manufacture have been set forth above. As for other details of the present invention, these may be appreciated in connection with the above-referencedpatents and publications as well as generally know or appreciated by those with skill in the art. For example, one with skill in the art will appreciate that a lubricious coating (e.g., hydrophilic polymers such as polyvinylpyrrolidone-basedcompositions, fluoropolymers such as tetrafluoroethylene, hydrophilic gel or silicones) may be used in connection with the devices, if desired, to facilitate low friction manipulation or advancement to the treatment site. The same may hold true withrespect to method-based aspects of the invention in terms of additional acts as commonly or logically employed.
In addition, though the invention has been described in reference to several examples, optionally incorporating various features, the invention is not to be limited to that which is described or indicated as contemplated with respect to eachvariation of the invention. Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of theinvention. In addition, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within theinvention.
Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein. Reference to a singular item, includesthe possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms "a," "an," "said," and "the" include plural referents unless the specifically stated otherwise. In otherwords, use of the articles allow for "at least one" of the subject item in the description above as well as the claims below. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended toserve as antecedent basis for use of such exclusive terminology as "solely," "only" and the like in connection with the recitation of claim elements, or use of a "negative" limitation.
Without the use of such exclusive terminology, the term "comprising" in the claims shall allow for the inclusion of any additional element--irrespective of whether a given number of elements are enumerated in the claim, or the addition of afeature could be regarded as transforming the nature of an element set forth n the claims. Except as specifically defined herein, all technical and scientific terms used herein are to be given as broad a commonly understood meaning as possible whilemaintaining claim validity.
The breadth of the present invention is not to be limited to the examples provided and/or the subject specification, but rather only by the scope of the claim language.
Field of SearchAnnular member for supporting artificial heart valve
Rotationally adjustable relative to suture ring
Having means for fixedly securing annular support member to sewing ring
Specific material for heart valve
Supported by frame